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      FDA醫療器械質量體系手冊框架介紹
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      Medical Device Quality Systems Manual

      醫療器械質量體系手冊

      A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)

      小實體企業認證指南第一版(用于取代原醫療器械GMP手冊)

      Chapters

      章節

      Cover page, Preface, Foreword

      首頁,前言

      Table of Contents

      目錄

      1. The Quality System Regulation

      1. 質量體系法規

      2. Quality Systems

      2. 質量體系

      3. Design Controls

      3. 設計控制

      4. Process Validation

      4. 流程驗證

      5. Personnel and Training

      5. 人員和培訓

      6. Buildings and Environment

      6. 建筑和環境

      7. Equipment and Calibration

      7. 設備和校準

      8. Device Master Record

      8. 器械主記錄

      9. Document and Change Control

      9. 文檔和變更控制

      10. Purchasing and Acceptance Activities

      10. 采購和接收活動

      11. Labeling

      11. 標簽

      12. Product Evaluation

      12. 產品評價

      13. Packaging

      13. 包裝

      14. Storage, Distribution and Installation

      14. 存儲,分發和安裝

      15. Complaints

      15. 投訴

      16. Servicing

      16. 售后服務

      17. Quality Systems Audits

      17. 質量體系審計

      18. Factory Inspections

      18. 工廠檢查

      19. Appendices

      19. 附件


      Cover page, Preface, Foreword
      HHS Publication FDA 97-4179
      首頁,前言

      MEDICAL DEVICE QUALITY SYSTEMS MANUAL:
      A SMALL ENTITY COMPLIANCE GUIDE
      First Edition
      (Supersedes the Medical Device Good Manufacturing Practices Manual)

      Andrew Lowery, Judy Strojny, and Joseph Puleo
      Division of Small Manufacturers Assistance
      Office of Health and Industry Programs

      CENTER FOR
      DEVICES AND
      RADIOLOGICAL HEALTH
      CDRH

      December 1996
      (This publication supersedes FDA 91-4179)

      U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
      Public Health Service
      Food and Drug Administration
      Center for Devices and Radiological Health
      Rockville, Maryland 20850

       

       


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